French prospective randomised double blind study on aspirin versus placebo in resected colon cancer with PI3K mutation stage III or II high risk (PRODIGE 50 - ASPIK)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Rouen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-09-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

PHRC 2015 · Bayer Healthcare SAS

External identifiers

EU CT number

2024-516007-16-00

EudraCT number

2016-002209-20

ClinicalTrials.gov

NCT02945033

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To test the effectiveness of aspirin on the disease-free survival at 3 years after curative surgery for colon adenocarcinoma with PI3K mutation

Secondary objectives 5

1. Overall survival at 5 years
2. Disease-free survival at 5 years
3. Adverse events grade 3 and 4 according to NCI-CTC version 4.0
4. Compliance: Collecting the users containers at each visit. The number of remaining tablets will be documented
5. Subgroups analyses regarding mutations (KRAS and BRAF) for DFS and OS

Conditions and MedDRA coding

Resected colon cancer with PI3K mutation stage III or II high risk

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Age ≥ 18 years
2. Colonic adenocarcinoma stage III (N+,M0) or Colonic adenocarcinoma stage II high risk MSS: a. T4bN0 or T4a tumour penetrating the surface of the visceral peritoneum; b. T3N0 with less than 12 nodes evaluated; c. T3N0 with at least 12 nodes evaluated but at least two of the following criteria: i. lymphatic involvement, ii. perineural invasion, iii. venous invasion; d. T3N0 with at least 12 nodes evaluated but at least one of the following criteria : i. diagnosis of bowel obstruction or perforation; ii. poor differentiated tumour.
3. PI3K mutation, exon 9 or 20 (tumour)
4. Status RAS known
5. Resection R0
6. WHO performance status 0-2
7. Chest and abdominal CT scan ≤ 12 weeks
8. Written consent signed
9. Women of childbearing age must agree to use effective contraception.

Exclusion criteria 11

1. Anticoagulant and/or Antiaggregating treatment including clopidogrel
2. Regular aspirin use (> 3 doses per week during more than 3 months the last year)
3. Follow-up of the patient not feasible for psychological, social or geographic reasons
4. Contraindication to Aspirin : Allergy to aspirin, Active or antecedent peptic ulcer
5. Severe renal or hepatic insufficiency
6. Pregnancy or nursing ongoing
7. Rectal cancer
8. Hereditary forms (i.e. lynch syndrome patients)
9. History of asthma induced by the administration of salicylate or close to active substances, including non-steroidal anti-inflammatory drugs
10. Constitutional or acquired haemorrhagic disease include gastrointestinal bleeding, history of haemorrhagic and thrombotic stroke
11. Uncontrolled heart failure

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease free survival at 3 years defined as the time from date of randomisation to date of first local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first

Secondary endpoints 7

1. Disease-free survival at 5 years
2. Overall survival at 5 years
3. Compliance to aspirin (comptability of containers)
4. Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0
5. Adverse event reported and graded according to NCI-CTC grading 4.0
6. Serious Adverse events will also be described
7. Subgroups analyses regarding mutations (KRAS and BRAF) for DFS and OS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Rouen

Sponsor organisation

Centre Hospitalier Universitaire Rouen

Address

1 Rue De Germont, Bp 96031 Bp 96031

City

Rouen Cedex

Postcode

76031

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

David MALLET

Public contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

David MALLET

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications